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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035076
Receipt No. R000039168
Official scientific title of the study Can I predict the effectiveness of medication therapy and risk of recurrence with preoperative examinations in GH-producing pituitary adenoma?
Date of disclosure of the study information 2018/12/01
Last modified on 2018/11/30

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Basic information
Official scientific title of the study Can I predict the effectiveness of medication therapy and risk of recurrence with preoperative examinations in GH-producing pituitary adenoma?
Title of the study (Brief title) Can I predict the effectiveness of medication therapy and risk of recurrence with preoperative examinations in GH-producing pituitary adenoma?
Region
Japan

Condition
Condition acromegaly
Classification by specialty
Endocrinology and Metabolism Endocrine surgery Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Can pre-operative evaluation predict the post-operative prognosis and effectiveness of medication therapy in acromegaly?
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Exploring pre-operative marker which can predict post-operative prognosis
Key secondary outcomes 1. relationship between diagnostic imaging study and hormonal findings

2. exploring effective factor of medication therapy

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with acromegaly based on `guideline of diagnosis and treatment with acromegaly` published by japan endocrine society.
Key exclusion criteria nothing
Target sample size 70

Research contact person
Name of lead principal investigator Masakatsu Sone
Organization Graduate school of medicine and faculty of medicine Kyoto university
Division name Department of diabetes, endocrinology and nutrition
Address 54 kawara-cho, shougoin, sakyou-ku, Kyoto city, Kyoto, Japan
TEL 075-751-3560
Email kyotorinsho@gmail.com

Public contact
Name of contact person Sachiko Kawashima
Organization Kyoto university hospital
Division name Department of diabetes, endocrinology and nutrition
Address 54 kawara-cho, shougoin, sakyou-ku, Kyoto city, Kyoto, Japan
TEL 075-751-3560
Homepage URL
Email kyotorinsho@gmail.com

Sponsor
Institute Graduate school of medicine and faculty of medicine Kyoto university
Institute
Department

Funding Source
Organization Graduate school of medicine and faculty of medicine Kyoto university
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 01 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 11 Month 30 Day
Anticipated trial start date
2018 Year 12 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information retrospective cross sectional study

Management information
Registered date
2018 Year 11 Month 30 Day
Last modified on
2018 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039168

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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